EFSA rejects Cargill’s health claim on erythritol and dental health

Cargill cannot prove a cause-and-effect relationship between eating sugar-free candy sweetened with at least 90% erythritol and a reduced risk of dental caries, the European Food Safety Authority (EFSA) has said.

Cargill’s R&D Centre Europe filed the request for an opinion on its erythritol sweetener, Zerose, in January this year.

The agri-food giant wanted to make the following claim on pack: “Sugar-free hard confectionery sweetened with at least 90% Zerose erythritol has been shown to reduce dental plaque. High content/level of dental plaque is a risk factor in the development of caries’.​

However, EFSA experts said they could not substantiate the proposed health claim, nor the mechanisms by which it was purported to work, due to an absence of evidence for an effect on the incidence of dental caries in vivo​ in humans.

“A cause and effect relationship between sugar-free hard confectionery with at least 90% erythritol and reduction of dental plaque which reduces the risk of dental caries has not been established,” ​the panel concluded.

In its application, Cargill said the dental health benefits could be seen with an intake of 2–3 g of candies sweetened with at least 90% erythritol at least three times per day. This applied to the general population, including children, from the age of five years and above.

Cargill claimed that erythritol reduced the build-up of dental plaque by limiting the growth and adherence of common streptococcal oral bacteria to tooth surfaces, and by reducing the amount of acid production by the bacteria.

A spokesperson for the company said it "​acknowledged and respected"​ the opinion, and would continue to focus on the European market to promote the sweetener.

"Despite EFSA’s opinion, we continue to be fully committed to advancing further demonstration of oral care benefits of Zerose erythritol. We will build further on the already existing authorised Article 13 claim on maintenance of tooth mineralisation by sugar replacers including erythritol as well as Article 14 claim on the reduction of risk factors for dental caries development by sugar free chewing-gums," ​the spokesperson added.

Erythritol is a low molecular weight polyol, comprised of four carbon atoms. It has zero calories, is non-glycaemic and non-insulinemic. As well as providing sweetness, erythritol has bulking properties similar to sugar which means it can be used in combination with other high intensity sweeteners to replace some of the functional properties of sugar.

It occurs naturally in many foods in low amounts, such as grapes and pears, and fermented foods, such as cheese, wine and soy sauce.

It is produced on a commercial scale by fermenting glucose with the yeast Moniliella pollinis​, and can be sold in Europe under the number E 968.

Cargill requested EFSA’s experts to evaluate the tooth decay-busting properties of Zerose specifically but, because it did not specify which properties were unique to Zerose​erythritol compared to other hard sweets that contain 90% erythritol, the food safety authority said there was no justification for a product-specific claim.

EFSA scientists also found flaws in the statistical analysis of one of the studies that was used. They wrote: “In weighing the evidence, the panel took into account that one human intervention study (reported in three publications) with some methodological limitations (e.g. data analysis in completers only) did not show an effect of sugar-free hard confectionery with at least 90% eryt​hritol on the incidence of dental caries in children on either mixed or permanent dentition.”​

Cargill's dossier was based on a three-year clinical study conducted by the Estonian University of Tartu’s department of stomatology. The findings were published in the 2013 issue of the Journal of Dentistry​ and the 2014 online edition of Caries Research​.

Sugar-free, hard confectionery applications for the sweetener used at a 90% concentration could include hard candies, pastilles, lozenges, tablets and breath-freshening microsweets.

The remaining 10% of the sweet could be made up of other ingredients, such as other sweeteners, bulking agents, hydrocolloids, flavourings and colours, Cargill said.

Last year, the ingredient supplier said it would be making investments to the tune of €35m​​ to expand its European sweetener portfolio in anticipation of EU sugar production quotas coming to an end.